Vein patch versus primary closure for carotid endarterectomy. A randomized prospective study in a selected group of patients.

During a 4-year period, 136 patients undergoing 152 carotid endarterectomies consented to be randomized to primary or saphenous vein patch closure of the arteriotomy. At operation, before randomization, careful assessment of arterial dimensions and anatomy was made. Patients who had an internal carotid artery (ICA) diameter less than 5 mm, arteriotomy extending more than 3 cm beyond the origin of the ICA, or tortuous or kinked ICAs were not randomized; they received obligatory vein patch closure (necessary in 20% cases). All patients were followed up every 3 months for 1 year and every 6 months thereafter with duplex scanning, ocular pneumoplethysmography, and neurologic assessment. The incidence of atherosclerotic risk factors was equal in the groups and all except one of the patients were male. Perioperative morbidity was not significantly different among those having primary closure (n = 60), saphenous vein patch closure (n = 62), and obligatory vein patch closure (n = 30). Operative time among patients having primary closure (122 +/- 4 minutes) was significantly less (p less than 0.001) than among those having saphenous vein patch closure (150 +/- 3 minutes). Three perioperative strokes were evenly distributed among the groups (2% for all procedures); no deaths and no acute postoperative occlusions occurred. Recurrent disease occurred in 12.9% of patients having saphenous vein patch closure compared with its occurrence in 1.7% of those having primary closure (p less than 0.05). However, most recurrences were moderate stenoses (25% to 50% diameter reduction), all were smooth-surfaced, and none required a second operation. All except one of the recurrences among those patients with saphenous vein patch closure were in the bulb and the origin of the ICA; two had evidence of regression. This finding suggested that thrombus layering in the dilated part of the saphenous vein patch reconstruction was the cause. This study demonstrates that in men with carotid arteries of predetermined minimal dimensions undergoing carotid endarterectomy routine saphenous vein patch closure does not produce superior results, is associated with a higher incidence of early recurrence, and increases operative time. In selected patients with anatomic risk factors for recurrent disease or acute postoperative occlusion, saphenous vein patch closure is appropriate.

RCT Entities:   Population Interventions Outcomes